Skip to contentDe Novo DEN220065
- Device
- Pill Sense System
- Contact
- david collins
- De Novo number
- DEN220065
- Product code
- QUD
- Regulation
- 876.1390
- Classification name
- blood detection capsule
- Decision
- granted (DENG)
- Decision date
- 2023-02-24
- Date received
- 2022-09-29
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QUD
- Device name
- Blood Detection Capsule
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.1390
- Implant
- N
- Life sustain/support
- N